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GLUCOTRACK ANNOUNCES EXPANSION OF ITS CONTINUOUS GLUCOSE MONITORING TECHNOLOGY TO EPIDURAL GLUCOSE MONITORING

GLUCOTRACK ANNOUNCES EXPANSION OF ITS CONTINUOUS GLUCOSE MONITORING TECHNOLOGY TO EPIDURAL GLUCOSE MONITORING

GLUCOTRACK 宣佈將其連續血糖監測技術擴展到硬膜外血糖監測
GlucoTrack ·  04/16 12:00

Expansion offers the potential for continuous, discreet and simplified epidural glucose monitoring solutions for patients with Painful Diabetic Neuropathy

擴張爲糖尿病痛性神經病患者提供持續、謹慎和簡化的硬膜外血糖監測解決方案提供了潛力

Rutherford, NJ, April  16, 2024   — Glucotrack, Inc. (Nasdaq: GCTK) ("Glucotrack" or the "Company"), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced that it is expanding its glucose monitoring technology to include measuring glucose in the epidural space. A continuous glucose monitoring system that takes readings in the spinal epidural space may be integrated with existing treatments for patients with Painful Diabetic Neuropathy (PDN).

新澤西州盧瑟福,2024年4月16日——專注於糖尿病患者新技術的設計、開發和商業化的醫療器械公司Glucotrack, Inc.(納斯達克股票代碼:GCTK)(“Glucotrack” 或 “公司”)宣佈正在擴展其血糖監測技術,將硬膜外領域的血糖測量包括在內。在脊柱硬膜外空間進行讀數的連續血糖監測系統可以與糖尿病疼痛性神經病變(PDN)患者的現有治療相結合。

PDN is a progressive neurological disorder that affects approximately one-fifth of the more than 38 million Americans with with diabetes, equating to more than 7 million individuals.1,2 Its symptoms include pain and numbness in the feet, legs, and hands which can significantly impact patients' quality of life and functional ability.3 Recently, Spinal Cord Stimulation (SCS) technology has been indicated as a treatment option providing significant long-term pain relief to these patients.4 A spinal cord stimulator is an implanted device, with electrodes placed in the epidural space, that sends low levels of electricity directly into the spinal cord to relieve pain.5 Glucotrack's sensor has the potential to be integrated with existing SCS devices to measure epidural glucose in patients with PDN who are undergoing SCS treatment. Combining SCS and continuous glucose monitoring (CGM) could provide several possible advantages, such as simplifying device management for those patients.

PDN 是一種進行性神經系統疾病,在3,800多萬美國糖尿病患者中,約有五分之一受到影響,相當於超過700萬人。1,2 其症狀包括腳、腿部和手部疼痛和麻木,這可能會嚴重影響患者的生活質量和功能能力。3 最近,脊髓刺激(SCS)技術被列爲一種治療方案,可以顯著緩解這些患者的長期疼痛。4 A 臍帶刺激器是一種植入式設備,其電極放置在硬膜外空間,可將低水平的電量直接輸送到脊髓以緩解疼痛。5 Glucotrack 的傳感器有可能與現有的 SCS 設備集成,用於測量正在接受 SCS 治療的 PDN 患者的硬膜外血糖。將SCS和持續血糖監測(CGM)相結合可以提供多種可能的優勢,例如簡化這些患者的設備管理。

Glucotrack has successfully completed preclinical animal testing in an acute setting. Building on the success of the acute studies, the Company has now initiated a long-term animal study to assess sustained epidural glucose monitoring performance. This is the second application of Glucotrack's technology for implantable continuous glucose monitoring, in addition to its development of a long-term Continuous Blood Glucose Monitoring (CBGM) system.

Glucotrack已成功完成了急性環境的臨床前動物試驗。在急性研究成功的基礎上,該公司現已啓動一項長期動物研究,以評估持續的硬膜外血糖監測性能。這是Glucotrack技術在植入式持續血糖監測方面的第二次應用,此外還開發了長期持續血糖監測(CBGM)系統。

The preclinical testing compared the Glucotrack sensor against blood glucose and a commercially available subcutaneous CGM in an acute large animal model while varying blood glucose levels for several hours. The results demonstrated the Glucotrack epidural glucose values closely tracked both the blood glucose and subcutaneous CGM values. The study was completed with no adverse effect on the animals. A second acute study successfully confirmed the repeatability of these results.

臨床前測試將Glucotrack傳感器與血糖和急性大型動物模型中的市售皮下CGM進行了比較,同時血糖水平變化了幾個小時。結果表明,Glucotrack硬膜外葡萄糖值與血糖和皮下CGM值密切相關。該研究已完成,對動物沒有不良影響。第二項急性研究成功證實了這些結果的可重複性。

"We have always been committed to developing a portfolio of innovative glucose monitoring technologies to offer patients with diabetes more choice; today's announcement underscores this commitment." said Paul V. Goode, PhD, CEO of Glucotrack. "We are excited to pioneer the epidural glucose monitoring space which we believe holds meaningful strategic potential. By making disease management more intuitive and less intrusive, Glucotrack is looking beyond traditional approaches to improve the quality of life for millions of people with diabetes."

Glucotrack首席執行官保羅·古德博士說:“我們一直致力於開發一系列創新的血糖監測技術,爲糖尿病患者提供更多選擇;今天的公告強調了這一承諾。”“我們很高興開創硬膜外血糖監測領域,我們認爲該領域具有重要的戰略潛力。通過使疾病管理更加直觀,減少干擾,Glucotrack正在超越傳統方法,改善數百萬糖尿病患者的生活質量。”

For more information about Glucotrack, visit glucotrack.com.

有關 Glucotrack 的更多信息,請訪問 glucotrack.com

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About Glucotrack, Inc.

關於 Glucotrack, Inc.

Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.

Glucotrack, Inc.(納斯達克股票代碼:GCTK)專注於爲糖尿病患者設計、開發和商業化新技術。該公司目前正在爲糖尿病患者開發一種長期植入式持續血糖監測系統。

Glucotrack's CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 2+ years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com.

Glucotrack 的 CBGM 是一種長期可植入的系統,可持續測量血糖水平,傳感器壽命爲 2 年以上,沒有機身可穿戴組件,校準也最少。欲了解更多信息,請訪問 http://www.glucotrack.com

Forward-Looking Statements

前瞻性陳述

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "believe", "expect", "plan" and "will" are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by the Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack's results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack's current and future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack's filings with the U.S. Securities and Exchange Commission (the "SEC"), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2023.

本新聞稿包含1995年《私人證券訴訟改革法》所指的前瞻性陳述。本新聞稿中包含的非歷史事實陳述的陳述可能被視爲前瞻性陳述。在不限制前述內容概括性的前提下,諸如 “相信”、“期望”、“計劃” 和 “將” 之類的詞語旨在識別前瞻性陳述。此類前瞻性陳述基於管理層的信念,以及管理層的假設和目前可獲得的信息。這些陳述僅涉及截至聲明發表之日的事件,除非法律要求,否則Glucotrack沒有義務公開更新任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。本新聞稿中發表的所有前瞻性陳述均受這些警示性陳述的限制,無法保證Glucotrack預期的實際業績會實現,即使已基本實現,也無法保證它們會對我們或我們的業務或運營產生預期的後果或影響。讀者請注意,某些重要因素可能會影響Glucotrack的實際業績,並可能導致此類業績與本新聞稿中可能發表的任何前瞻性陳述存在重大差異。可能影響Glucotrack業績的因素包括但不限於Glucotrack籌集額外資金爲其運營提供資金的能力(無論是通過公開還是私募股權發行、債務融資、戰略合作或其他方式);與獲得監管批准(包括美國食品藥品監督管理局批准)(包括美國食品藥品監督管理局批准)(和時機)相關的風險;與Glucotrack註冊和進行臨床試驗相關的風險;與Glucotrack業績相關的風險 cotrack 當前和未來的分銷協議;與其相關的風險僱用和留住合格人員(包括銷售和分銷人員)的能力;以及Glucotrack向美國證券交易委員會(“SEC”)提交的文件中描述的其他風險因素,包括其於2023年3月28日向美國證券交易委員會提交的截至2023年12月31日的10-K表年度報告。

Contacts:

聯繫人:

Investor Relations:
investors@glucotrack.com

投資者關係:
investors@glucotrack.com

References:

參考文獻:

1 Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care 2011;34:2220-2224.
2 Centers for Disease Control and Prevention. (2022). National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html
3 Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354. doi:10.1097/00002508-200211000-00002.
4 Erika A. Petersen, Thomas G. Stauss, James A. Scowcroft, Elizabeth S. Brooks, Judith L. White, Shawn M. Sills, Kasra Amirdelfan, Maged N. Guirguis, Jijun Xu, Cong Yu, Ali Nairizi, Denis G. Patterson, Kostandinos C. Tsoulfas, Michael J. Creamer, Vincent Galan, Richard H. Bundschu, Neel D. Mehta, Dawood Sayed, Shivanand P. Lad, David J. DiBenedetto, Khalid A. Sethi, Johnathan H. Goree, Matthew T. Bennett, Nathan J. Harrison, Atef F. Israel, Paul Chang, Paul W. Wu, Charles E. Argoff, Christian E. Nasr, Rod S. Taylor, David L. Caraway, Nagy A. Mekhail; Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care 5 January 2022; 45 (1): e3-e6. https://doi.org/10.2337/dc21-1813
5 Dydyk AM, Tadi P. Spinal Cord Stimulator Implant. [Updated 2023 Jul 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK555994/

1 Abbott CA、Malik RA、van Ross ER、Kulkarni J、Boulton AJ。《2011年英國糖尿病護理》中大量社區糖尿病患者中疼痛性糖尿病神經病變的患病率和特徵;34:2220-2224。
2 美國疾病控制與預防中心。(2022年)。全國糖尿病統計報告網站。 https://www.cdc.gov/diabetes/data/statistics-report/index.html
3 Schmader KE。帶狀皰疹後神經痛和糖尿病性神經病變的流行病學及其對生活質量的影響。Clin J Pain。2002;18 (6): 350-354. doi: 10.1097/00002508-200211000-00002。
4 埃裏卡·A·彼得森、托馬斯·施陶斯、詹姆斯·斯考克羅夫特、伊麗莎白·布魯克斯、朱迪思·懷特、肖恩·西爾斯、卡斯拉·阿米爾德爾凡、馬吉德·吉爾吉斯、徐繼軍、餘聰、阿里·奈裏齊、丹尼斯·帕特森、科斯坦迪諾斯·索爾法斯、邁克爾·克雷默、文森特·加蘭、理查德·邦德舒和尼爾·梅赫 Ta、Dawood Sayed、Shivanand P. Lad、David J. Dibenedetto、Khalid A. Sethi、Johnathan H. Goree、Matthew T. Bennett、Nathan J. Harrison、Atef F. Israel、Paul W. W.W.Wu、Charles E. Argoff、Charles E. Nasr、David S. Taylor、David L. Caraway、Nagy A. Mekhail;耐久性對傳統治療難以治癒的疼痛性糖尿病神經病患者的高頻 10kHz 脊髓刺激:一項隨機對照試驗的 12 個月結果。2022年1月5日糖尿病護理;45(1):e3-e6。 https://doi.org/10.2337/dc21-1813
5 Dydyk AM,Tadi P. 脊髓刺激器植入物。[2023 年 7 月 3 日更新]。在:StatPearls [互聯網]。金銀島(佛羅里達州):StatPearls 出版社;2024 年 1 月可從以下地址獲得: https://www.ncbi.nlm.nih.gov/books/NBK555994/

譯文內容由第三人軟體翻譯。


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